Job Description: QC Instrumentation Senior Specialist

Location: Dublin

Duration: Initial 12 Month Contract

Our client a leading biologics manufacturer is seeking a QC Instrumentation Specialist to oversee the procurement, installation, qualification, and lifecycle management of laboratory instrumentation. Reporting to the QC Instrumentation Team Lead, this role involves managing the calibration and maintenance services for QC laboratory instruments.

Key Responsibilities:

Provide calibration and maintenance services for QC laboratory instruments, including scheduling and tracking.

Review and approve documentation related to instrument qualification, calibration, and repairs.

Ensure maintenance and verification processes align with instrument use.

Manage investigations related to instrument calibration deviations.

Monitor and manage instrument performance and lifecycle.

Participate in the selection and qualification of new instruments.

Collaborate with QC specialists, QA validation specialists, and Computer System Validation personnel to qualify new instruments.

Liaise with sister sites and vendors regarding instrument procurement, qualification, and lifecycle management.

Ensure compliance with corporate policies and regulatory requirements for instrument qualification, calibration, and lifecycle management.

Develop and establish procedures related to instrumentation.

Troubleshoot complex instrumentation issues.

Qualifications and Skills:

Minimum B.Sc. in a scientific discipline

At least 3 years' experience in a GMP laboratory setting, with at least 1 year focused on instrument qualification

Experience with data integrity management (21 CFR 11/EU Annex 11) is preferred.

Fundamental understanding of protein biochemistry is desirable

Technical expertise in Biopharmaceutical analytical platforms such as HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF, and Liquid Handlers

Experience with technology transfers is advantageous

Strong team collaboration skills and the ability to lead

Excellent time management, organisational skills, and communication abilities

The Next Step for you:

Should this position be of interest to you please forward your CV to Barry O'Mahony from Next Generation Recruitment or alternatively call on the main line on 016629120

Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.

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